Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy

Launched by AVERITAS PHARMA, INC. · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective the repeated use of QUTENZA® is for people suffering from painful diabetic peripheral neuropathy (PDPN), a condition that causes pain in the feet and legs due to diabetes. The study aims to gather real-world evidence on whether using QUTENZA can help reduce pain and the need for other pain medications in patients. The trial is not yet recruiting participants, but when it starts, it will include men and women aged 18 to 80 who have been diagnosed with painful diabetic neuropathy and have experienced moderate pain in the past week.

To be eligible for the study, individuals must provide written consent and have stable pain medication for at least four weeks before joining. They should have a specific type of nerve pain confirmed by a questionnaire and be willing to follow proper foot care methods. However, certain conditions, like other types of leg pain or skin issues, may exclude someone from participating. If you join the trial, you can expect to be monitored for your pain levels and any changes in your medication use while using QUTENZA. This study could be a valuable opportunity to help improve pain management for those affected by this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. IRB approved written Informed Consent and privacy language as per national regulations will be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
• • 2. Male or female 18 - 80 years of age
• • 3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes confirmed by the Douleur Neuropathique 4 Interview (DN4I) of at least 3 out of 7
• • 4. Baseline PROMIS-29 numeric pain intensity score over the last 7 days ≥ 4 during the screening period
• • 5. Stable doses of pain medications for PDPN for more than 4 weeks prior to the screening visit
• • 6. Patient agreed not to participate in another interventional study while on treatment
• Exclusion Criteria:
• • 1. Pain associated with PDPN in the ankles or above
• • 2. Pain that could not be clearly differentiated from, or conditions that might have interfered with the assessment of the PDPN, such as plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (eg, phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (eg, plantar ulcer)
• • 3. Significant pain (moderate or above) of an etiology other than PDPN (eg, compression-related neuropathies \[eg, spinal stenosis\]), fibromyalgia or arthritis, that may interfere with assessment of PDPN-related pain
• • 4. Current foot ulcer or not intact skin as determined by medical examination
• • 5. Clinically significant foot deformities or foot amputations
• • 6. Any active signs of skin inflammation around onychomycosis sites such as pain, redness, swelling or drainage
• • 7. Patient is unwilling to implement proper foot care methods
• • 8. Diagnosis of any poorly controlled major psychiatric disorder at the Investigator's discretion
• • 9. Evidence of cognitive impairment including dementia that may interfere with patient's ability to complete pain assessments requiring patient's recall of average pain level in the past 24 hours
• • 10. Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to have reoccurred during the study period as judged by the Investigator
• • 11. Participation in any other PDPN related clinical study within 30 days prior to the screening visit
• • 12. Previous treatment with QUTENZA
• • 13. Hypersensitivity to capsaicin (eg, chili peppers or over-the-counter capsaicin products) or any QUTENZA excipients
• • 14. Active malignancy or history of malignancy during the past 5 years prior to screening visit (a history of squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed)
• • 15. Use of transcutaneous nerve or spinal cord stimulators to relieve pain
• • 16. Patient, who in the opinion of the Investigator, is not likely to complete the study for any reason